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Case C: Coordinating CA NCAR

  1. Select the Coordinating CA NCAR category in the first field of the NCAR Registration section:

    EUDAMED NCAR category drop-down list with Coordinating CA NCAR selected

  2. Select Yes or No in the Manufacturer field, as shown below:

    EUDAMED Yes or No question: Is the MF registered in EUDAMED

  3. Specify if the Manufacturer has an Authorised Representative:

    EUDAMED Yes or No question: Is an AR applicable

  4. Provide reference to a Vigilance report:

    EUDAMED Form type drop-down and Vigilance item - reference from EUDAMED drop-down
    EUDAMED Form type selection example, MIR

  5. Provide any useful and relevant comments in the description fields under Additional information:

    EUDAMED Additional information section fields: Comments, Background information, Conclusions, Recommendations

  6. Submission:

    Submit the report by clicking on the blue Submit button on the top right corner:

    EUDAMED Submit button

  7. Finalise the submission of the report by clicking on Complete action in the pop-up window:

    EUDAMED submission pop-up window with Complete action button and alternative Close button